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 @ 2:20 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
NCT ID:
NCT01146834
Description:
Arm D and Arm E did not enrolled any patients
Frequency Threshold:
0
Time Frame:
Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Study:
NCT01146834
Study Brief:
Trial of Three Stem Cell Mobilization Regimens for Multiple Myeloma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF | VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached. bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11 cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C) G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D) | 0 | None | 0 | 20 | 8 | 20 | View |
| Arm B: VELCADE & G-CSF | VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11 G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D) | 0 | None | 0 | 4 | 4 | 4 | View |
| Arm C: CYCLOPHOSPHAMIDE & G-CSF | High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached. cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C) G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D) | 0 | None | 1 | 23 | 18 | 23 | View |
| Arm D: PLERIXAFOR & G-CSF | G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status. G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D) Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E) | 0 | None | 0 | 0 | 0 | 0 | View |
| Arm E: PLERIXAFOR, VELCADE, & G-CSF | Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status. bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11 G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D) Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E) | 0 | None | 0 | 0 | 0 | 0 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Gallbladder Pain | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Serum creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| INR increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Flu like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gastroesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Gingival pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| bloating | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vulval infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Chest wall pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Papulopustular rash | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Joint range of motion decreased lumbar spine | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Skin ulceration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Thrombotic thrombocytopenic purpura | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Other, Eye twitch | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| bruising; extremity | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Mucosal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Injection Site Reaction | SYSTEMATIC_ASSESSMENT | General disorders | None | View |