ISRCTN42955626 Confidential once completed Please answer all the questions

eGFR-C – SERIOUS ADVERSE EVENT (SAE) FORM

Please report immediately any SERIOUS ADVERSE EVENTS (see eGFR-C Protocol, Section 9 for definition) occurring within 24 hoursof iohexol administration, by completing all of the details below and faxing this form to the eGFR-C Trial Office on 0121 415 9135. Please also complete the SAE form if the patient dies.

eGFR-C Study Number: / iiI iiI iiI ii iiI ii / Date of Birth: / MiiMiMi/ YiiiYiiiYiiiYii
Responsible study clinician: / Hospital Name:
Patient sex: / ii iiMale ii iiFemale
Current Patient Height (cm): / I iii iiiiii.ii ii / Current Patient Weight (kg): / IiiiI iii ii.ii ii
Is this report: / Initial Report / Follow-up Report / Final Report
Seriousness of event (please provide a response to each question) / Yes / No / Details
Death / If Yes, date of death
iDiiDi/ MiiMiiMi/ YiiiYiiiYiiiYii
Category of death: …………… (1 – Cancer, 2 – Cardiovascular, 3 – Cerebrovascular, 4 – Renal, 5 – Hepatic, 6 – Respiratory, 7 – Neurodegenerative, 8 – Accidental (death not caused by disease), 9 – Other)
Cause of death: ……………………………………………………………………………………….
Life threatening event
In-patient hospitalisation or prolongation of existing hospitalisation / If Yes, Initial Prolonged
If Yes, number of days spent in hospital as result of the SAE
Persistent or significant disability/incapacity
Congenital abnormality or birth defect
Other pertinent medical reason for reporting? / If Yes, please specify: ………………………………………………………………………
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Date Event Started / iDiiDi/ MiiMiiMi/ YiiiYiiiYiiiYii
CTCAE category / I i iPlease refer to coded list on Page 4

Serious adverse event description: include a) diagnosis, b) changes in medications, c) relevant investigation results, d) treatment of the SAE,e) location. (Please answer all points a-e and attach copies of relevant reports).

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PTO

Details of relevant medical history (indicate if medical history is considered ‘nil relevant’)

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Iohexol administration causality assessment
The assessment of causality must be provided by a clinician
Date of iohexol administration / Causality Assessment
1 Unrelated to iohexol administration
2 Unlikely to be related to iohexol administration
3 Possibly related to iohexol administration
4 Probably related to iohexol administration
5 Definitely related to iohexol administration / Action taken due to SAE
1 Iohexol administration discontinued – no iohexol to be administered in the future
2Considered safe to administer further iohexol in the future
3 Unknown
4 N/A
DD/MMM/YYYY / I i / I i
Please give reasons why you consider the event to be related to the iohexol administration
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Did iohexol administration cause an anaphylactoid reaction? Yes No N/A
If Yes, what treatment was the patient given?
Antihistamine Corticosteroid Adrenaline Other if Other please specify: ………………………………………………………
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Was the SAE unexpected, i.e. of a type or severity which is NOT consistent with the up-to-date product information? This section must be completed by a clinician.

Unexpected / Expected / Unrelated
If Unexpected, please give reasons why you consider the event to be unexpected: …………………………………………………………………………………
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Concomitant Medication

Please provide details of other medication the patient was taking prior to the event:

Drug Name (give generic name) / Start date / Tick if continuing or specify stop date / Dose / Unit / Freq-uency / Route / Indication
Please refer to coded list on Page 4
______/ DD/ MMM/ YYYY / DD/ MMM/ YYYY
______/ DD/ MMM/ YYYY / DD/ MMM/ YYYY
______/ DD/ MMM/ YYYY / DD/ MMM/ YYYY
______/ DD/ MMM/ YYYY / DD/ MMM/ YYYY
______/ DD/ MMM/ YYYY / DD/ MMM/ YYYY
______/ DD/ MMM/ YYYY / DD/ MMM/ YYYY

PTO

What was the final outcome of the event?
Resolved no sequelae / If Resolved, date of resolution: iDiiDi/ MiiMiiMi/ YiiiYiiiYiiiYii
Resolved with sequelae / If Resolved, date of resolution: iDiiDi/ MiiMiiMi/ YiiiYiiiYiiiYii
Specific sequelae: …………………………………………………………………………………………………………………………………………....
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Continuing / If Continuing, please provide date of resolution on follow-up/final SAE form
Fatal

Details of person reporting:

Signature of Person Reporting (you must be listed on the site delegation log): / Name of Person Reporting:
Position:
Telephone Number: / Email Address:
Fax Number: / Date of reporting:
iDiiDi / MiiMiiMi / YiiiYiiiYiiYii
Signature of Principal Investigator (if not reported by PI):
SUSAR Reporting For BCTU use only / Date reported to BCTU?
iDiiDi / MiiMiiMi / YiiiYiiiYiiYii
Date reported to CI?
iDiiDi / MiiMiiMi / YiiiYiiiYiiYii / Date reply received from CI?
iDiiDi / MiiMiiMi / YiiiYiiiYiiYii
Is this event a SUSAR? / No  Is this a SAE? No Yes
Yes  7 day report OR 15 day report
CI comments: ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………
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CI signature: / Date: iDiiDi / MiiMiiMi / YiiiYiiiYiiYii
Due to be reported to Ethics Committee / Date: iDiiDi / MiiMiiMi / YiiiYiiiYiiYii

PTO for Coded Reference Lists

Coded Reference Lists

Common Terminology Criteria for Adverse Events v3.0 (CTCAE Coded List)
Code / Category / Code / Category
1 / Allergy/Immunology / 15 / Infection
2 / Auditory/Ear / 16 / Lymphatics
3 / Blood/Bone Marrow / 17 / Metabolic/Laboratory
4 / Cardiac Arrhythmia / 18 / Musculoskeletal/Soft Tissue
5 / Cardiac General / 19 / Neurology
6 / Coagulation / 20 / Ocular/Visual
7 / Constitutional Symptoms / 21 / Pain
8 / Death / 22 / Pulmonary/Upper Respiratory
9 / Dermatology/Skin / 23 / Renal/Genitourinary
10 / Endocrine / 24 / Secondary Malignancy
11 / Gastrointestinal / 25 / Sexual/Reproductive Function
12 / Growth And Development / 26 / Surgery/Intra-Operative Injury
13 / Hemorrhage/Bleeding / 27 / Syndromes
14 / Hepatobiliary/Pancreas / 28 / Vascular
Concomitant Medication Codes (Units, Route, Frequency)
Unit Codes / Route Code / Frequency Code
1 / mg / 1 / Intra-arterial / 1 / Twice a day
2 / µg / 2 / Intraperitoneal / 2 / Three times a day
3 / g / 3 / Intravenous / 3 / Four times a day
4 / puffs / 4 / Oral / 4 / Hourly
5 / units / 5 / Respiratory (inhalation) / 5 / 4 hourly
6 / ml / 6 / Subcutaneous / 6 / Daily
7 / mg/ml / 7 / Topical / 7 / Alternate days
8 / mg/kg / 8 / Suppository / 8 / As desired
9 / µg/ml / 9 / Intra-occular / 9 / If necessary
10 / AUC / 10 / Intramuscular / 10 / Slow release
97 / Other, specify / 97 / Other, specify / 97 / Other, specify
99 / Not known / 99 / Not known / 99 / Not known

eGFR-C Study Office, Birmingham Clinical Trials Unit, College of Medical & Dental Sciences, Robert Aitken Institute, University of Birmingham, Edgbaston,

Birmingham, B15 2TT

Tel: 0121 415 9130 Fax: 0121 415 9135

eGFR-CStudy Website:

eGFR-CStudy Mailbox:

When you have faxed the form, please then send this form (with copies of any relevant reports) to the eGFR-C Study Office, Birmingham Clinical Trials Unit, College of Medical & Dental Sciences, Robert Aitken Institute, University of Birmingham, Edgbaston, Birmingham, B15 2TT.

eGFR-C SAE FormPage 1 of 4Version 1.0 14th Feb 2014