NCT01633541 · ADVERSE EVENTS

Adverse events

Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Organ Preservation In Adults With Advanced Laryngeal Cancer · Source last updated 2023-07-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Platinum/Docetaxal + AT-101 platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist. Patients underwent induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6). (AT-101 Arm) Days #1-3: Patients received AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy. AT-101: Patients received AT-101 40 mg orally two times a day. Cisplatin: Cisplatin 100 mg/m2 Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg	14 / 36	36 / 36	1 / 36
Active Comparator Arm (Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6). Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies. Docetaxel: Docetaxel (Taxotere) 75 mg/m2 Cisplatin: Cisplatin 100 mg/m2 Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg	5 / 18	18 / 18	1 / 18

Group identifiers: EG000: Platinum/Docetaxal + AT-101 · EG001: Active Comparator Arm

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
term
Adult respiratory distress syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Allergic reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
term
Confusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Cause of death larynx cancer.
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Disease Progression
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
36
num Events
3
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Squamous Cell Carcinoma - Nose
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
36
num Events
2
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
2
term
Dysphagia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
36
num Events
5
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Dyspnea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Acute Kidney injury

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Abdominal distention
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Acne
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
36
num Events
4
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Alanine aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
2
group Id
EG001
num Affected
3
num At Risk
18
num Events
5
term
Alkaline phosphatase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
36
num Events
2
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Allergic reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
36
num Events
4
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
7
num At Risk
36
num Events
7
group Id
EG001
num Affected
5
num At Risk
18
num Events
6
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
9
num At Risk
36
num Events
9
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Anxiety
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
36
num Events
7
group Id
EG001
num Affected
2
num At Risk
18
num Events
3
term
Aspartate aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Back pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Blurred vision

Complete source fields

event Groups

deaths Num Affected
1
deaths Num At Risk
36
description
platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist. Patients underwent induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6). (AT-101 Arm) Days #1-3: Patients received AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy. AT-101: Patients received AT-101 40 mg orally two times a day. Cisplatin: Cisplatin 100 mg/m2 Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
id
EG000
other Num Affected
36
other Num At Risk
36
serious Num Affected
14
serious Num At Risk
36
title
Platinum/Docetaxal + AT-101
deaths Num Affected
1
deaths Num At Risk
18
description
(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6). Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies. Docetaxel: Docetaxel (Taxotere) 75 mg/m2 Cisplatin: Cisplatin 100 mg/m2 Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
id
EG001
other Num Affected
18
other Num At Risk
18
serious Num Affected
5
serious Num At Risk
18
title
Active Comparator Arm

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Abdominal distention
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Acne
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
36
num Events
4
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Alanine aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
2
group Id
EG001
num Affected
3
num At Risk
18
num Events
5
term
Alkaline phosphatase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
36
num Events
2
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Allergic reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
36
num Events
4
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
7
num At Risk
36
num Events
7
group Id
EG001
num Affected
5
num At Risk
18
num Events
6
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
9
num At Risk
36
num Events
9
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Anxiety
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
36
num Events
7
group Id
EG001
num Affected
2
num At Risk
18
num Events
3
term
Aspartate aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Back pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Blurred vision

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
term
Adult respiratory distress syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Allergic reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
36
num Events
1
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
term
Confusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Cause of death larynx cancer.
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Disease Progression
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
36
num Events
3
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Squamous Cell Carcinoma - Nose
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
36
num Events
2
group Id
EG001
num Affected
0
num At Risk
18
num Events
0
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
2
term
Dysphagia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
36
num Events
5
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Dyspnea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
36
num Events
0
group Id
EG001
num Affected
1
num At Risk
18
num Events
1
term
Acute Kidney injury

time Frame

All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 6.5 year period.

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