UKALL14 CRF Adverse Event Induction Phase 2 - v3.0 - 27Nov15

Sep 19, 2026

Upload by Gloria

Adverse event case report form for Induction Phase 2, covering day 1 through the day before the next treatment phase starts. Captures whether any adverse events occurred, then records each event’s maximum severity grade, date of onset, and causal relationships to Oncaspar, Rituximab, Nelarabine, and Palifermin, along with outcome and whether the event is serious. Includes dedicated sections for infection adverse events with organism/pathogen code and for other adverse events using CTCAE v4.0 terms, plus completion instructions and submission fields.

LanguageEnglish

CategoryForms

FormatPDF

Pages5

Reading Time2 min

AccessFree to download

Adverse event induction phase overview

Treatment phase adverse event occurrence

Non-infection adverse events table

Infection adverse events suspected or proven

Other adverse events table

Completion and return instructions

| Phase 2 Induction (Day 1 Phase 2 to the day before next treatment phase begins) | Has the patient experienced any adverse events during this treatment phase? (1=Yes, 2=No) | | | | --- | --- | --- | --- | | Adverse Event
(Pages 1-2: Please report a maximum severity grade for all adverse events listed) | Maximum
Severity
Grade1
(Grades 0-5) | Date of Onset
dd/mm/yyyy | Causally
related to
Oncaspar?2 | Causally
related to
Rituximab?2 | Causally
related to
Nelarabine?2 | Causally
related to Palifermin?2 | Outcome3 | Was the
event
serious?4
0 = No
1 = Yes
2=Yes, but
SAE Report
not required | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Anaemia | | | | | | | | | | Agitation | | | | | | | | | | Allergic Reaction | | | | | | | | | | Alopecia | | | | | | | | | | Anorexia | | | | | | | | | | Arthralgia | | | | | | | | | | Depression | | | | | | | | | | Diarrhoea | | | | | | | | | | Disseminated Intravascular Coagulation | | | | | | | | | | Erythema Multiforme | | | | | | | | | | Febrile Neutropenia | | | | | | | | | | Fever | | | | | | | | | | Adverse Event
(Pages 1-2: Please report a maximum severity grade for all adverse events listed) | Maximum
Severity
Grade1
(Grades 0-5) | Date of Onset
dd/mm/yyyy | Causally
related to
Oncaspar?2 | Causally
related to
Rituximab?2 | Causally
related to
Nelarabine?2 | Causally
related to Palifermin?2 | Outcome3 | Was the
event
serious?4
0 = No
1 = Yes
2=Yes, but
SAE Report
not required | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Headache | | | | | | | | | | Serum Amylase Increased | | | | | | | | | | Hypertriglyceridemia | | | | | | | | | | White Blood Cell Decreased | | | | | | | | | | Nausea | | | | | | | | | | Neutrophil Count Decreased | | | | | | | | | | Pruritus | | | | | | | | | | Seizure | | | | | | | | | | Skin hyperpigmentation | | | | | | | | | | Stroke | | | | | | | | | | Thromboembolic event | If a thromboembolic event has occurred, please report on either a Thromboembolic Event Form or SAE Report as appropriate | | | | | | | | | Weight Loss | | | | | | | | | | Infection Adverse Events Suspected or Proven
(Page 3: Please report a maximum severity grade for all infection adverse events listed below and use the blank rows to report all other infection adverse events using CTCAEv4.0 terms) | Maximum
Severity
Grade1
(0-5) | Date of onset
dd/mm/yyyy | Causally
related to
Oncaspar?2 | Causally
related to
Rituximab?2 | Causally
related to
Nelarabine?2 | Causally
related to Palifermin?2 | Outcome3 | Was the
event
serious?4
0 = No
1 = Yes
2= Yes, but
SAE Report
not required | Organism/Pathogen Involved5 Please give Code + Pathogen name | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Catheter related infection | | | | | | | | | | | Device related infection | | | | | | | | | | | Gum infection | | | | | | | | | | | Lung infection | | | | | | | | | | | Mucosal infection | | | | | | | | | | | Skin infection | | | | | | | | | | | Upper respiratory infection | | | | | | | | | | | Urinary tract infection | | | | | | | | | | | Sepsis | | | | | | | | | | | | | | | | | | | | | | 5) Enter code and pathogen , if not proven, please report this as ‘not done’ or ‘unknown’ accordingly.
Bacterial: 1=Coagulase-negative staphylococcus; 2=S. pneumonia; 3=Other gram positive (i.e: other streptococci, staphylococci, listeria ); 4=Haemophilus influenza; 5=Other gram negative (i.e: E.coli, klebsiella, proteus, serratia, pseudomonas); 6=Legionella sp; 7=Mycobacteria sp; 8=Other bacterial infection
Fungal: 9=Candida

FAQs

How is adverse event reporting handled for Induction Phase 2?

Use the form to report the maximum severity grade of all adverse events occurring during the specified treatment phase. If no adverse events occurred, record this at the top of page 1 and no other data are required.

Which fields are collected for each adverse event?

For each adverse event, the form collects maximum severity grade, date of onset, causal relationships to Oncaspar, Rituximab, Nelarabine, and Palifermin, outcome, and whether the event is serious.

How should infection adverse events be documented?

Report infection adverse events with a maximum severity grade and date of onset, causal links to the study drugs, and whether the event is serious. Provide the organism/pathogen involved using the required code and pathogen name.

Sep 19, 2026

Upload by Gloria