Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 4:24 AM
Ignite Modification Date: 2025-12-26 @ 3:27 AM
NCT ID: NCT00047320
Description: 104 patients enrolled, 2 are ineligible and not included in adverse event reporting. Therefore, adverse events participants reported is 102.
Frequency Threshold: 5
Time Frame: None
Study: NCT00047320
Study Brief: Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Radiation Therapy (CR From Induction) Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC \> 750/L and platelets \> 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy. carboplatin: Given IV etoposide: Given IV ifosfamide: Given IV radiation therapy: craniospinal irradiation None None 8 102 70 102 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia None Blood and lymphatic system disorders None View
Nausea None Gastrointestinal disorders None View
Lymphocyte count decreased None Investigations None View
Neutrophil count decreased None Investigations None View
Platelet count decreased None Investigations None View
White blood cell decreased None Investigations None View
Hyperkalemia None Metabolism and nutrition disorders None View
Hypernatremia None Metabolism and nutrition disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Hypophosphatemia None Metabolism and nutrition disorders None View
Headache None Nervous system disorders None View
Seizure None Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Platelet count decreased None Investigations None View
Hyperkalemia None Metabolism and nutrition disorders None View
Hypermagnesemia None Metabolism and nutrition disorders None View
Hypernatremia None Metabolism and nutrition disorders None View
Hypomagnesemia None Metabolism and nutrition disorders None View
Anemia None Blood and lymphatic system disorders None View
Febrile neutropenia None Blood and lymphatic system disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Infections and infestations - Other, specify None Infections and infestations None View
Alanine aminotransferase increased None Investigations None View
Aspartate aminotransferase increased None Investigations None View
Lymphocyte count decreased None Investigations None View
Neutrophil count decreased None Investigations None View
White blood cell decreased None Investigations None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hypoalbuminemia None Metabolism and nutrition disorders None View
Hypocalcemia None Metabolism and nutrition disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Hypophosphatemia None Metabolism and nutrition disorders None View
Headache None Nervous system disorders None View