Trial Outcomes & Findings for AZD1775 Plus Carboplatin-Paclitaxel in Squamous Cell Lung Cancer (NCT NCT02513563)
NCT ID: NCT02513563
Last Updated: 2025-11-18
Results Overview
PFS is measured from date of first study treatment to death, progression of disease, or the last follow-up data, whichever comes first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2025-11-18
Participant Flow
Participant milestones
| Measure |
Carboplatin/Paclitaxel/AZD1775
Treatment: Combination of AZD1775 plus carboplatin and paclitaxel. Participants will be treated with this combination of drugs twice daily on days 1 and 2 and once on day 3 for a total of 5 doses during each 21 day cycle of treatment.
Carboplatin: Participants will be treated with carboplatin (area under the curve 5 (AUC5) will be used to determine the dosage) twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
Paclitaxel: Participants will be treated with paclitaxel 175 mg/m\^2 twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
AZD1775: Participants will receive AZD1775 225 mg twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Carboplatin/Paclitaxel/AZD1775
Treatment: Combination of AZD1775 plus carboplatin and paclitaxel. Participants will be treated with this combination of drugs twice daily on days 1 and 2 and once on day 3 for a total of 5 doses during each 21 day cycle of treatment.
Carboplatin: Participants will be treated with carboplatin (area under the curve 5 (AUC5) will be used to determine the dosage) twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
Paclitaxel: Participants will be treated with paclitaxel 175 mg/m\^2 twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
AZD1775: Participants will receive AZD1775 225 mg twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
|
|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
AZD1775 Plus Carboplatin-Paclitaxel in Squamous Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Carboplatin/Paclitaxel/AZD1775
n=42 Participants
Treatment: Combination of AZD1775 plus carboplatin and paclitaxel. Participants will be treated with this combination of drugs twice daily on days 1 and 2 and once on day 3 for a total of 5 doses during each 21 day cycle of treatment.
Carboplatin: Participants will be treated with carboplatin (area under the curve 5 (AUC5) will be used to determine the dosage) twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
Paclitaxel: Participants will be treated with paclitaxel 175 mg/m\^2 twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
AZD1775: Participants will receive AZD1775 225 mg twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=202 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=202 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=202 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=202 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=202 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=202 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=202 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=202 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=202 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=202 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=202 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=202 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Evaluable participants
PFS is measured from date of first study treatment to death, progression of disease, or the last follow-up data, whichever comes first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Carboplatin/Paclitaxel/AZD1775
n=41 Participants
Treatment: Combination of AZD1775 plus carboplatin and paclitaxel. Participants will be treated with this combination of drugs twice daily on days 1 and 2 and once on day 3 for a total of 5 doses during each 21 day cycle of treatment.
Carboplatin: Participants will be treated with carboplatin (area under the curve 5 (AUC5) will be used to determine the dosage) twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
Paclitaxel: Participants will be treated with paclitaxel 175 mg/m\^2 twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
AZD1775: Participants will receive AZD1775 225 mg twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
|
|---|---|
|
Progression Free Survival (PFS)
|
4.8 months
Interval 4.1 to 5.7
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Evaluable participants
OS is defined as the duration of time from the date for first treatment (Cycle 1 Day 1) to the date of death.
Outcome measures
| Measure |
Carboplatin/Paclitaxel/AZD1775
n=41 Participants
Treatment: Combination of AZD1775 plus carboplatin and paclitaxel. Participants will be treated with this combination of drugs twice daily on days 1 and 2 and once on day 3 for a total of 5 doses during each 21 day cycle of treatment.
Carboplatin: Participants will be treated with carboplatin (area under the curve 5 (AUC5) will be used to determine the dosage) twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
Paclitaxel: Participants will be treated with paclitaxel 175 mg/m\^2 twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
AZD1775: Participants will receive AZD1775 225 mg twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
|
|---|---|
|
Overall Survival (OS)
|
7.3 months
Interval 6.4 to 8.4
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Evaluable participants
The duration of overall response is measured from the time measurement criteria are met for Complete Response (CR) or Partial Response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Carboplatin/Paclitaxel/AZD1775
n=14 Participants
Treatment: Combination of AZD1775 plus carboplatin and paclitaxel. Participants will be treated with this combination of drugs twice daily on days 1 and 2 and once on day 3 for a total of 5 doses during each 21 day cycle of treatment.
Carboplatin: Participants will be treated with carboplatin (area under the curve 5 (AUC5) will be used to determine the dosage) twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
Paclitaxel: Participants will be treated with paclitaxel 175 mg/m\^2 twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
AZD1775: Participants will receive AZD1775 225 mg twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
|
|---|---|
|
Duration of Overall Response (OR)
|
4.4 months
Interval 3.2 to 4.9
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Evaluable participants
DCR: Complete Response (CR), Partial Response (PR), and Stable Disease (SD).
Outcome measures
| Measure |
Carboplatin/Paclitaxel/AZD1775
n=41 Participants
Treatment: Combination of AZD1775 plus carboplatin and paclitaxel. Participants will be treated with this combination of drugs twice daily on days 1 and 2 and once on day 3 for a total of 5 doses during each 21 day cycle of treatment.
Carboplatin: Participants will be treated with carboplatin (area under the curve 5 (AUC5) will be used to determine the dosage) twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
Paclitaxel: Participants will be treated with paclitaxel 175 mg/m\^2 twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
AZD1775: Participants will receive AZD1775 225 mg twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
|
|---|---|
|
Percentage of Participants With Disease Control
|
61 percentage
Interval 51.0 to 71.0
|
Adverse Events
Carboplatin/Paclitaxel/AZD1775
Serious events: 26 serious events
Other events: 40 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Carboplatin/Paclitaxel/AZD1775
n=42 participants at risk
Treatment: Combination of AZD1775 plus carboplatin and paclitaxel. Participants will be treated with this combination of drugs twice daily on days 1 and 2 and once on day 3 for a total of 5 doses during each 21 day cycle of treatment.
Carboplatin: Participants will be treated with carboplatin (area under the curve 5 (AUC5) will be used to determine the dosage) twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
Paclitaxel: Participants will be treated with paclitaxel 175 mg/m\^2 twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
AZD1775: Participants will receive AZD1775 225 mg twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
|
|---|---|
|
Infections and infestations
Lung infection
|
11.9%
5/42 • Number of events 7 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
14.3%
6/42 • Number of events 7 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.5%
4/42 • Number of events 4 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
General disorders
General disorders and administration site conditions -Other
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
General disorders
Generalized edema
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Nervous system disorders
Stroke
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
General disorders
Death NOS
|
7.1%
3/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.1%
3/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Nervous system disorders
Seizure
|
2.4%
1/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
General disorders
Fatigue
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Nervous system disorders
Somnolence
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
3/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Nausea
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Renal and urinary disorders
Renal failure
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Renal and urinary disorders
Renal calculi
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Infections and infestations
Infections and Infestations - Other
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.1%
3/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Vascular disorders
Hypotension
|
7.1%
3/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
2/42 • Number of events 4 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Cardiac disorders
Heart failure
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
General disorders
Localized edema
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Investigations
Platelet count decreased
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Cardiac disorders
Cardiac arrest
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
General disorders
Infusion related reaction
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Investigations
Pancytopenia
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Infections and infestations
Pleural infection
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Enterocolitis
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Investigations
White blood cell decreased
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Cardiac disorders
Chest pain - Cardiac
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
General disorders
Non-cardiac chest pain
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders -Other
|
7.1%
3/42 • Number of events 5 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Cardiac disorders
Pericardial tamponade
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
General disorders
Pain in extremity
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Esophagitis
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Vascular disorders
Thromboembolic event
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
General disorders
Pain
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Ascites
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Peritonitis
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Infections and infestations
Sepsis
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Nervous system disorders
Syncope
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
3/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Vascular disorders
Hypertension
|
2.4%
1/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.4%
1/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Gastric ulcer
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
Other adverse events
| Measure |
Carboplatin/Paclitaxel/AZD1775
n=42 participants at risk
Treatment: Combination of AZD1775 plus carboplatin and paclitaxel. Participants will be treated with this combination of drugs twice daily on days 1 and 2 and once on day 3 for a total of 5 doses during each 21 day cycle of treatment.
Carboplatin: Participants will be treated with carboplatin (area under the curve 5 (AUC5) will be used to determine the dosage) twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
Paclitaxel: Participants will be treated with paclitaxel 175 mg/m\^2 twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
AZD1775: Participants will receive AZD1775 225 mg twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
21/42 • Number of events 34 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Nausea
|
47.6%
20/42 • Number of events 31 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
12/42 • Number of events 16 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Abdominal Pain
|
21.4%
9/42 • Number of events 10 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
7/42 • Number of events 8 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.4%
1/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Dry mouth
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Dysphagia
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Enterocolitis
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Ileus
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Mucositis oral
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Oral pain
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Rectal ulcer
|
2.4%
1/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Gastrointestinal disorders
Stomach pain
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
General disorders
Fatigue
|
50.0%
21/42 • Number of events 37 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
General disorders
Pain
|
23.8%
10/42 • Number of events 14 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
General disorders
Infusion related reaction
|
14.3%
6/42 • Number of events 9 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
General disorders
Chills
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
General disorders
Edema limbs
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
General disorders
Fever
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
General disorders
Malaise
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
General disorders
Non-cardiac chest pain
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
General disorders
Death NOS
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
General disorders
Edema face
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
General disorders
Localized edema
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
7/42 • Number of events 7 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.9%
5/42 • Number of events 8 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.9%
5/42 • Number of events 9 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.9%
5/42 • Number of events 6 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.5%
4/42 • Number of events 4 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.1%
3/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.8%
2/42 • Number of events 6 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
2.4%
1/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.4%
9/42 • Number of events 13 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
14.3%
6/42 • Number of events 6 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
3/42 • Number of events 4 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
3/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
7.1%
3/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.8%
2/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Blood and lymphatic system disorders
Anemia
|
40.5%
17/42 • Number of events 28 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.1%
3/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
16.7%
7/42 • Number of events 8 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.5%
4/42 • Number of events 5 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Nervous system disorders
Dysgeusia
|
7.1%
3/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Nervous system disorders
Headache
|
7.1%
3/42 • Number of events 4 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Nervous system disorders
Dizziness
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Nervous system disorders
Neuralgia
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Nervous system disorders
Aphonia
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Nervous system disorders
Cognitive disturbance
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Nervous system disorders
Nervous system disorders - Other
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Nervous system disorders
Paresthesia
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Nervous system disorders
Somnolence
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Nervous system disorders
Syncope
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
4/42 • Number of events 4 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
2/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
2/42 • Number of events 4 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness trunk
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.9%
5/42 • Number of events 5 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.9%
5/42 • Number of events 7 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
3/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Investigations
Neutrophil count decreased
|
7.1%
3/42 • Number of events 5 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Investigations
Investigations - Other
|
4.8%
2/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Investigations
White blood cell decreased
|
4.8%
2/42 • Number of events 4 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Investigations
Alkaline phosphatase increased
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Investigations
Blood bilirubin increased
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Investigations
Creatinine increased
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Investigations
Lymphocyte count decreased
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Investigations
Platelet count decreased
|
2.4%
1/42 • Number of events 4 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Investigations
Weight loss
|
2.4%
1/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Infections and infestations
Infections and infestations - Other
|
7.1%
3/42 • Number of events 4 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Infections and infestations
Lung infection
|
7.1%
3/42 • Number of events 6 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Infections and infestations
Upper respiratory infection
|
7.1%
3/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Infections and infestations
Urinary tract infection
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Infections and infestations
Enterocolitis infectious
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Infections and infestations
Paronychia
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Infections and infestations
Pleural infection
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
3/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Renal and urinary disorders
Hematuria
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Renal and urinary disorders
Renal calculi
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Renal and urinary disorders
Urinary retention
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Renal and urinary disorders
Urinary tract pain
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Vascular disorders
Hypotension
|
9.5%
4/42 • Number of events 4 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Vascular disorders
Thromboembolic event
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Vascular disorders
Hypertension
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Cardiac disorders
Chest pain - cardiac
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Cardiac disorders
Heart failure
|
4.8%
2/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Cardiac disorders
Sinus tachycardia
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Cardiac disorders
Cardiac disorders - Other
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Cardiac disorders
Pericardial tamponade
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Psychiatric disorders
Insomnia
|
7.1%
3/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Psychiatric disorders
Anxiety
|
4.8%
2/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Psychiatric disorders
Confusion
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
7.1%
3/42 • Number of events 3 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
|
Injury, poisoning and procedural complications
Fracture
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events were collected from date of consent until 4 weeks after last study treatment. Adverse Events were collected from treatment Cycle 1 day 1 until 4 weeks after last study treatment. Events were collected an average of 129 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place