Trial Outcomes & Findings for Trial of BIBW 2992 (Afatinib) + Cetuximab in Non-Small Cell Lung Cancer (NCT NCT01090011)

NCT ID: NCT01090011

Last Updated: 2015-10-02

Results Overview

A DLT was defined as an AE or laboratory abnormality that a) related to the study regimen; b) or met any of the following criteria: * CTCAE Grade 2 or higher decrease in cardiac left ventricular function * CTCAE Grade 2 diarrhea lasting for 7 or more days, despite appropriate use of standard anti-diarrheal therapy * CTCAE Grade ≥3 diarrhea despite appropriate use of standard anti-diarrheal therapy for at least 2 days * CTCAE Grade ≥3 nausea and/or vomiting despite appropriate use of standard anti-emetics for at least 3 days * CTCAE Grade ≥3 rash despite standard medical management * CTCAE Grade ≥3 fatigue lasting for more than 7 days * CTCAE Grade 4 hypomagnesaemia or Grade 3 hypomagnesaemia with clinical significant sequelae * All other toxicities of CTCAE Grade ≥3 (except alopecia, and allergic reaction) leading to an interruption of afatinib and/or cetuximab for more than 14 days until recovery to baseline or Grade 1, whichever was higher.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

171 participants

Primary outcome timeframe

from day 1 treatment until progression or undue toxicity, up to 28 days

Results posted on

2015-10-02

Participant Flow

171 patients were entered and treated in the study.

Participant milestones

Participant milestones
Measure
Total Patients
All patients entered and treated. The objective of this study was to determine the maximum tolerated dose of Afatinib using a "3+3 Up-and-Down" trial design. Cohorts of three to six participants were entered (not randomized) sequentially into escalating dosage tiers of afatinib/cetuximab. The dose of cetuximab in successive cohorts was increased unless two or more of the six participants (of the current cohort) had dose limiting toxicity events.
Overall Study
STARTED
171
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
171

Reasons for withdrawal

Reasons for withdrawal
Measure
Total Patients
All patients entered and treated. The objective of this study was to determine the maximum tolerated dose of Afatinib using a "3+3 Up-and-Down" trial design. Cohorts of three to six participants were entered (not randomized) sequentially into escalating dosage tiers of afatinib/cetuximab. The dose of cetuximab in successive cohorts was increased unless two or more of the six participants (of the current cohort) had dose limiting toxicity events.
Overall Study
Progressive disease
128
Overall Study
Adverse Event
32
Overall Study
Protocol Violation
1
Overall Study
Refusal to start/continue medication
5
Overall Study
Other reason not defined above
5

Baseline Characteristics

Trial of BIBW 2992 (Afatinib) + Cetuximab in Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Total Patients
n=171 Participants
All patients entered and treated. The objective of this study was to determine the maximum tolerated dose of Afatinib using a "3+3 Up-and-Down" trial design. Cohorts of three to six participants were entered (not randomized) sequentially into escalating dosage tiers of afatinib/cetuximab. The dose of cetuximab in successive cohorts was increased unless two or more of the six participants (of the current cohort) had dose limiting toxicity events.
Age, Continuous
58.1 years
STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male
Female
119 Participants
n=5 Participants
Sex: Female, Male
Male
52 Participants
n=5 Participants

PRIMARY outcome

Timeframe: from day 1 treatment until progression or undue toxicity, up to 28 days

Population: Treated set for Cohort One. Cohort one was based on the data from the first treatment cycle where four patients received 'Afatinib 40+Cetuximab 250' and six patients received 'Afatinib 40+Cetuximab 500'.

A DLT was defined as an AE or laboratory abnormality that a) related to the study regimen; b) or met any of the following criteria: * CTCAE Grade 2 or higher decrease in cardiac left ventricular function * CTCAE Grade 2 diarrhea lasting for 7 or more days, despite appropriate use of standard anti-diarrheal therapy * CTCAE Grade ≥3 diarrhea despite appropriate use of standard anti-diarrheal therapy for at least 2 days * CTCAE Grade ≥3 nausea and/or vomiting despite appropriate use of standard anti-emetics for at least 3 days * CTCAE Grade ≥3 rash despite standard medical management * CTCAE Grade ≥3 fatigue lasting for more than 7 days * CTCAE Grade 4 hypomagnesaemia or Grade 3 hypomagnesaemia with clinical significant sequelae * All other toxicities of CTCAE Grade ≥3 (except alopecia, and allergic reaction) leading to an interruption of afatinib and/or cetuximab for more than 14 days until recovery to baseline or Grade 1, whichever was higher.

Outcome measures

Outcome measures
Measure
Combination Arm - Afa40+Ctx250
n=4 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=6 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
The Primary Endpoint is the Occurrence of Dose Limiting Toxicity (DLT).
0 participants
0 participants

SECONDARY outcome

Timeframe: From first drug administration to 28 days after discontinuation of drug intake up to 915 days

Population: Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.

Safety of afatinib when administered together with cetuximab as indicated by intensity and incidence of adverse events, graded according to the U.S. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version (v) 3.0

Outcome measures

Outcome measures
Measure
Combination Arm - Afa40+Ctx250
n=4 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=126 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
n=37 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
n=36 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Highest CTCAE Grade
Patients with highest CTCAE Grade 1
0 percentage of patients
0.8 percentage of patients
10.8 percentage of patients
2.8 percentage of patients
Highest CTCAE Grade
Patients with highest CTCAE Grade 2
25.0 percentage of patients
26.2 percentage of patients
24.3 percentage of patients
19.4 percentage of patients
Highest CTCAE Grade
Patients with highest CTCAE Grade 3
50.0 percentage of patients
54.0 percentage of patients
48.6 percentage of patients
52.8 percentage of patients
Highest CTCAE Grade
Patients with highest CTCAE Grade 4
25.0 percentage of patients
4.0 percentage of patients
5.4 percentage of patients
8.3 percentage of patients
Highest CTCAE Grade
Patients with highest CTCAE Grade 5
0 percentage of patients
15.1 percentage of patients
10.8 percentage of patients
16.7 percentage of patients

SECONDARY outcome

Timeframe: From first drug administration to 28 days after discontinuation of drug intake up to 915 days

Population: Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.

Outcome measures

Outcome measures
Measure
Combination Arm - Afa40+Ctx250
n=4 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=126 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
n=37 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
n=36 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters
Haemoglobin - low (N=4,124,35,35)
0 percentage of patients
12.9 percentage of patients
20.0 percentage of patients
2.9 percentage of patients
Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters
White blood cell ct. - low (N=4,124,35,35)
0 percentage of patients
3.2 percentage of patients
0 percentage of patients
2.9 percentage of patients
Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters
Neutrophils - low (N=4,124,35,35)
0 percentage of patients
4.0 percentage of patients
0 percentage of patients
2.9 percentage of patients
Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters
Sodium - low (N=4,124,35,35)
0 percentage of patients
5.6 percentage of patients
0 percentage of patients
2.9 percentage of patients
Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters
Potassium - low (N=4,124,35,35)
0 percentage of patients
5.6 percentage of patients
2.9 percentage of patients
5.7 percentage of patients
Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters
Potassium - high (N=4,124,35,35)
0 percentage of patients
4.0 percentage of patients
0 percentage of patients
0 percentage of patients
Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters
Calcium - low (N=4,124,35,35)
0 percentage of patients
6.5 percentage of patients
8.6 percentage of patients
5.7 percentage of patients
Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters
Calcium - high (N=4,124,35,35)
0 percentage of patients
1.6 percentage of patients
0 percentage of patients
0 percentage of patients
Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters
Magnesium - low (N=4,124,34,35)
0 percentage of patients
9.7 percentage of patients
0 percentage of patients
11.4 percentage of patients
Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters
AST/GOT, SGOT - high (N=4,123,35,35)
0 percentage of patients
3.3 percentage of patients
0 percentage of patients
2.9 percentage of patients
Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters
ALT/GPT, SGPT - high (N=4,123,35,35)
0 percentage of patients
11.4 percentage of patients
0 percentage of patients
8.6 percentage of patients
Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters
Alkaline phosphatase - high (N=4,124,35,35)
25.0 percentage of patients
4.8 percentage of patients
2.9 percentage of patients
5.7 percentage of patients
Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters
Blood urea nitrogen - high (N=missing,105,28,28)
0 percentage of patients
5.7 percentage of patients
3.6 percentage of patients
0 percentage of patients
Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters
Creatinine - high (N=4,123,33,35)
0 percentage of patients
2.4 percentage of patients
0 percentage of patients
0 percentage of patients
Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters
Creatinine clearance - low (N=4,123,33,35)
0 percentage of patients
3.3 percentage of patients
0 percentage of patients
2.9 percentage of patients
Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters
Bilirubin,total - high (N=4,124,35,35)
0 percentage of patients
4.8 percentage of patients
2.9 percentage of patients
5.7 percentage of patients
Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters
Sodium - high (N=4,124,35,35)
0 percentage of patients
0.8 percentage of patients
0 percentage of patients
0 percentage of patients

SECONDARY outcome

Timeframe: From first drug administration to 28 days after discontinuation of drug intake up to 915 days

Population: Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.

Outcome measures

Outcome measures
Measure
Combination Arm - Afa40+Ctx250
n=4 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=126 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
n=37 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
n=36 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Frequency (%) of Patients With Adverse Events Leading to Dose Reduction
25.0 percentage of patients
37.3 percentage of patients
13.5 percentage of patients
22.2 percentage of patients

SECONDARY outcome

Timeframe: From first drug administration to 28 days after discontinuation of drug intake up to 915 days

Population: Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.

Frequency (%) of patients with adverse events leading to treatment discontinuation

Outcome measures

Outcome measures
Measure
Combination Arm - Afa40+Ctx250
n=4 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=126 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
n=37 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
n=36 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Frequency (%) of Patients With Adverse Events Leading to Treatment Discontinuation
50.0 percentage of patients
23.8 percentage of patients
2.7 percentage of patients
19.4 percentage of patients

SECONDARY outcome

Timeframe: From first drug administration to 28 days after discontinuation of drug intake up to 915 days

Population: Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.

Outcome measures

Outcome measures
Measure
Combination Arm - Afa40+Ctx250
n=4 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=126 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
n=37 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
n=36 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Frequency (%) of Patients With Adverse Events Leading to Death
0.0 percentage of patients
15.1 percentage of patients
10.8 percentage of patients
16.7 percentage of patients

SECONDARY outcome

Timeframe: From first drug administration to 28 days after discontinuation of drug intake up to 915 days

Population: Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.

Frequency (%) of patients with drug-related serious adverse events

Outcome measures

Outcome measures
Measure
Combination Arm - Afa40+Ctx250
n=4 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=126 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
n=37 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
n=36 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Frequency (%) of Patients With Related Serious Adverse Events
0.0 percentage of patients
10.3 percentage of patients
5.4 percentage of patients
2.8 percentage of patients

SECONDARY outcome

Timeframe: Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55

Population: Pharmacokinetic dataset (PKS)

Area Under the Concentration-time Curve (AUC) of Afatinib in plasma at steady state over a uniform dosing interval tau (15 days) (AUCtau,ss) after oral administration of Afatinib and cetuximab combination therapy

Outcome measures

Outcome measures
Measure
Combination Arm - Afa40+Ctx250
n=3 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=20 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Area Under the Concentration-time Curve (AUC) on Day 15 of Plasma Afatinib for the Combination Arm
1300 ng*h/mL
Geometric Coefficient of Variation 21.8
935 ng*h/mL
Geometric Coefficient of Variation 59.8

SECONDARY outcome

Timeframe: Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55

Population: Pharmacokinetic dataset (PKS)

Minimum measured concentration of Afatinib in plasma at steady state over 15 day dosing interval (Cmin,ss). Maximum measured concentration of Afatinib in plasma at steady state over 15 day dosing interval (Cmax,ss).

Outcome measures

Outcome measures
Measure
Combination Arm - Afa40+Ctx250
n=3 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=24 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Concentration of Afatinib in Plasma for the Combination Arm
Cmin,ss,15
33.9 ng/mL
Geometric Coefficient of Variation 19.6
24.4 ng/mL
Geometric Coefficient of Variation 53.7
Concentration of Afatinib in Plasma for the Combination Arm
Cmax,ss,15
83.8 ng/mL
Geometric Coefficient of Variation 19.8
52.3 ng/mL
Geometric Coefficient of Variation 73.2

SECONDARY outcome

Timeframe: Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55

Population: Pharmacokinetic dataset (PKS)

Peak-trough fluctuation (PTF) of plasma afatinib for the combination arm. PTF = 100\*(Cmax-Cmin)/Caverage where Caverage = AUC/time, where time equals 24 hours.

Outcome measures

Outcome measures
Measure
Combination Arm - Afa40+Ctx250
n=3 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=20 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Peak-trough Fluctuation (PTF)
91.6 % of average concentration
Geometric Coefficient of Variation 15.9
73.8 % of average concentration
Geometric Coefficient of Variation 55.2

SECONDARY outcome

Timeframe: Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55

Population: Pharmacokinetic dataset (PKS)

Terminal half-life of Afatinib in plasma at steady state (t1/2,ss)

Outcome measures

Outcome measures
Measure
Combination Arm - Afa40+Ctx250
n=3 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=21 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
t1/2,ss
22.4 h
Geometric Coefficient of Variation 24.5
NA h
Geometric Coefficient of Variation NA
No descriptive statistics calculated due to insufficient number of participants with data

SECONDARY outcome

Timeframe: Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55

Population: Pharmacokinetic dataset (PKS)

mean residence time of Afatinib in the body at steady state after oral administration (MRTpo,ss) for 15 days

Outcome measures

Outcome measures
Measure
Combination Arm - Afa40+Ctx250
n=3 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=20 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
MRTpo,ss
32.6 h
Geometric Coefficient of Variation 23.4
NA h
Geometric Coefficient of Variation NA
no descriptive statistics calculated due to insufficient number of participants with data

SECONDARY outcome

Timeframe: Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55

Population: Pharmacokinetic dataset (PKS)

Apparent clearance of afatinib in plasma at steady state after extravascular multiple dose administration (CL/F,ss)

Outcome measures

Outcome measures
Measure
Combination Arm - Afa40+Ctx250
n=3 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=20 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
CL/F,ss,15
511 mL/min
Geometric Coefficient of Variation 21.8
713 mL/min
Geometric Coefficient of Variation 59.8

SECONDARY outcome

Timeframe: Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55

Population: Pharmacokinetic dataset (PKS)

Apparent volume of distribution during the terminal phase λz at steady state following extravascular administration (Vz/F,ss) for 15 days

Outcome measures

Outcome measures
Measure
Combination Arm - Afa40+Ctx250
n=3 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=21 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Vz/F,ss
991 L
Geometric Coefficient of Variation 44.8
NA L
Geometric Coefficient of Variation NA
no descriptive statistics calculated due to insufficient number of participants with data

SECONDARY outcome

Timeframe: Up to 57 days

Population: Pharmacokinetic dataset (PKS)

Predose plasma concentrations (Cpre,ss) of Afatinib at Course 1, Visit 2, 3, 4 and 5, at Course 2, Visit 1 and 2 and at Course 3, Visit 1.

Outcome measures

Outcome measures
Measure
Combination Arm - Afa40+Ctx250
n=4 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=28 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Predose Plasma Concentrations of Afatinib for the Combination Arm
Cpre,ss,8 (N=4,25)
33.2 ng/mL
Geometric Coefficient of Variation 38.3
28.3 ng/mL
Geometric Coefficient of Variation 62.3
Predose Plasma Concentrations of Afatinib for the Combination Arm
Cpre,ss,15 (N=3,28)
33.9 ng/mL
Geometric Coefficient of Variation 19.6
27.1 ng/mL
Geometric Coefficient of Variation 51.3
Predose Plasma Concentrations of Afatinib for the Combination Arm
Cpre,ss,16 (N=3,0)
36.4 ng/mL
Geometric Coefficient of Variation 15.8
NA ng/mL
Geometric Coefficient of Variation NA
no descriptive statistics calculated due to insufficient number of participants with data
Predose Plasma Concentrations of Afatinib for the Combination Arm
Cpre,ss,22 (N=3,21)
33.5 ng/mL
Geometric Coefficient of Variation 1.30
28.3 ng/mL
Geometric Coefficient of Variation 64.3
Predose Plasma Concentrations of Afatinib for the Combination Arm
Cpre,ss,29 (N=3,20)
33.4 ng/mL
Geometric Coefficient of Variation 21.8
27.7 ng/mL
Geometric Coefficient of Variation 56.8
Predose Plasma Concentrations of Afatinib for the Combination Arm
Cpre,ss,43 (N=3,19)
33.5 ng/mL
Geometric Coefficient of Variation 14.9
26.0 ng/mL
Geometric Coefficient of Variation 98.4
Predose Plasma Concentrations of Afatinib for the Combination Arm
Cpre,ss,57 (N=3,0)
36.6 ng/mL
Geometric Coefficient of Variation 4.51
NA ng/mL
Geometric Coefficient of Variation NA
no descriptive statistics calculated due to insufficient number of participants with data

SECONDARY outcome

Timeframe: up to 116 weeks

Population: Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), At least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesion(s); Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Disease control = CR + PR + SD.

Outcome measures

Outcome measures
Measure
Combination Arm - Afa40+Ctx250
n=4 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=126 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
n=37 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
n=36 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Disease Control (CR, PR and Stable Disease (SD) Determined by RECIST v1.1)
75.0 percentage of patients
Interval 19.4 to 99.4
70.6 percentage of patients
Interval 61.9 to 78.4
56.8 percentage of patients
Interval 39.5 to 72.9
50.0 percentage of patients
Interval 32.9 to 67.1

SECONDARY outcome

Timeframe: up to 116 weeks

Population: Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), At least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesion(s); Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Objective tumor response = CR + PR.

Outcome measures

Outcome measures
Measure
Combination Arm - Afa40+Ctx250
n=4 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=126 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
n=37 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
n=36 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Objective Tumor Response (Complete Response [CR] and Partial Response [PR]) Determined by RECIST v1.1)
0.0 percentage of patients
28.6 percentage of patients
5.4 percentage of patients
11.1 percentage of patients

SECONDARY outcome

Timeframe: up to 116 weeks

Population: Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.

Duration of objective response was measured from the time measurements criteria were met for CR/PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded since treatment started).

Outcome measures

Outcome measures
Measure
Combination Arm - Afa40+Ctx250
n=4 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=126 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
n=37 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
n=36 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Duration of Objective Response (According to RECIST v1.1)
0 months
Standard Deviation 0
9.00 months
Standard Deviation 6.94
3.90 months
Standard Deviation 0.07
5.80 months
Standard Deviation 2.36

SECONDARY outcome

Timeframe: up to 116 weeks

Population: Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.

Duration of disease control was defined as the time from the start of treatment to the time of progression or death (whichever occurred first), among patients with evidence SD, PR or CR.

Outcome measures

Outcome measures
Measure
Combination Arm - Afa40+Ctx250
n=4 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=126 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
n=37 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
n=36 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Duration of Disease Control (According to RECIST v1.1)
7.40 months
Standard Deviation 5.54
7.40 months
Standard Deviation 5.45
4.90 months
Standard Deviation 3.08
5.90 months
Standard Deviation 4.51

SECONDARY outcome

Timeframe: up to 116 weeks

Population: Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.

Progression-Free Survival was defined as the duration of time from start of treatment until the day of objective tumour progression confirmed by tumour imaging (PD according to RECIST 1.1) or death.

Outcome measures

Outcome measures
Measure
Combination Arm - Afa40+Ctx250
n=4 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=126 Participants
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
n=37 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
n=36 Participants
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Progression-Free Survival (PFS) Time
4.2 months
Interval 1.4 to 13.8
4.6 months
Interval 4.2 to 6.3
2.7 months
Interval 1.1 to 3.7
2.9 months
Interval 1.8 to 4.8

Adverse Events

Combination Arm - Afa40+Ctx250

Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths

Combination Arm - Afa40+Ctx500

Serious events: 63 serious events
Other events: 126 other events
Deaths: 0 deaths

Sequential Arm - Afatanib Monotherapy (Afa40 Mono)

Serious events: 12 serious events
Other events: 36 other events
Deaths: 0 deaths

Sequential Arm - Combination Therapy (Afa40+Ctx500)

Serious events: 15 serious events
Other events: 36 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Combination Arm - Afa40+Ctx250
n=4 participants at risk
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=126 participants at risk
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
n=37 participants at risk
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
n=36 participants at risk
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Cardiac disorders
Atrial fibrillation
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Endocrine disorders
Steroid withdrawal syndrome
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Eye disorders
Diplopia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Abdominal distension
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Abdominal pain
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Ascites
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Diarrhoea
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
3.2%
4/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Dysphagia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Gastritis
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Nausea
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
3.2%
4/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Vomiting
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
4.8%
6/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.1%
3/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Catheter site pain
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Chest pain
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Chills
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Death
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Fatigue
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.4%
3/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
General physical health deterioration
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Mucosal inflammation
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Oedema peripheral
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Pain
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Pyrexia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Sudden death
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Hepatobiliary disorders
Hepatic failure
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Hepatobiliary disorders
Hepatic function abnormal
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Immune system disorders
Drug hypersensitivity
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.4%
3/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Immune system disorders
Hypersensitivity
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Cellulitis
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Cystitis
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Gastroenteritis
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Gastroenteritis viral
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Infectious pleural effusion
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Meningitis aseptic
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Pneumonia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.4%
3/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.3%
3/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Sepsis
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Streptococcal infection
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Urinary tract infection
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Viral infection
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Injury, poisoning and procedural complications
Fall
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Injury, poisoning and procedural complications
Femur fracture
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Injury, poisoning and procedural complications
Hip fracture
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Injury, poisoning and procedural complications
Spinal compression fracture
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Injury, poisoning and procedural complications
Spinal fracture
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Investigations
Biopsy lung
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Metabolism and nutrition disorders
Dehydration
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
4.0%
5/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Metabolism and nutrition disorders
Failure to thrive
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Metabolism and nutrition disorders
Hypercalcaemia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Musculoskeletal and connective tissue disorders
Spinal pain
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
50.0%
2/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
4.8%
6/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
11.1%
4/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Nervous system disorders
Cerebrovascular accident
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Nervous system disorders
Convulsion
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
3.2%
4/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Nervous system disorders
Depressed level of consciousness
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Nervous system disorders
Dizziness
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Nervous system disorders
Drug withdrawal headache
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Nervous system disorders
Embolic cerebral infarction
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Nervous system disorders
Generalised tonic-clonic seizure
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Nervous system disorders
Headache
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Nervous system disorders
Spinal cord compression
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Nervous system disorders
Syncope
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Psychiatric disorders
Confusional state
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Psychiatric disorders
Hallucination
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Psychiatric disorders
Mental status changes
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
11.1%
14/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
3.2%
4/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Lung infiltration
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
4.8%
6/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Surgical and medical procedures
Pain management
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Surgical and medical procedures
Surgery
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Vascular disorders
Deep vein thrombosis
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Vascular disorders
Embolism
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Vascular disorders
Hypotension
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Blood and lymphatic system disorders
Leukocytosis
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.

Other adverse events

Other adverse events
Measure
Combination Arm - Afa40+Ctx250
n=4 participants at risk
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
Combination Arm - Afa40+Ctx500
n=126 participants at risk
Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Sequential Arm - Afatanib Monotherapy (Afa40 Mono)
n=37 participants at risk
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
Sequential Arm - Combination Therapy (Afa40+Ctx500)
n=36 participants at risk
Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
Metabolism and nutrition disorders
Hypercalcaemia
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.4%
3/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Blood and lymphatic system disorders
Anaemia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
4.0%
5/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.3%
3/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Ear and labyrinth disorders
Ear pain
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Ear and labyrinth disorders
Ear pruritus
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Eye disorders
Dry eye
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
10.3%
13/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.3%
3/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Eye disorders
Eye irritation
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
7.1%
9/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Eye disorders
Lacrimation increased
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
7.1%
9/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Eye disorders
Vision blurred
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
6.3%
8/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
13.9%
5/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Abdominal pain
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
7.9%
10/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Abdominal pain upper
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
3.2%
4/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Aphthous stomatitis
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Cheilitis
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
10.3%
13/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.1%
3/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Constipation
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
25.4%
32/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.1%
3/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
16.7%
6/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Diarrhoea
50.0%
2/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
73.0%
92/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
73.0%
27/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
36.1%
13/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Dry mouth
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
11.1%
14/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
11.1%
4/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Glossodynia
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
4.0%
5/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Haemorrhoids
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
3.2%
4/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Large intestinal haemorrhage
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Lip dry
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Nausea
75.0%
3/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
50.8%
64/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
29.7%
11/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
33.3%
12/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Oral pain
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
6.3%
8/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Stomatitis
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
12.7%
16/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
10.8%
4/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.3%
3/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Tongue ulceration
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Gastrointestinal disorders
Vomiting
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
40.5%
51/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
18.9%
7/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
16.7%
6/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Asthenia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
7/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.3%
3/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Chest discomfort
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
3.2%
4/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Chest pain
50.0%
2/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
4.8%
6/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Chills
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
11.1%
14/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.3%
3/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Face oedema
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Fatigue
75.0%
3/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
54.8%
69/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
43.2%
16/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
38.9%
14/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Feeling cold
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
7/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Mucosal inflammation
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
25.4%
32/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
10.8%
4/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Oedema peripheral
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
9.5%
12/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.1%
3/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
11.1%
4/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Metabolism and nutrition disorders
Decreased appetite
50.0%
2/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
22.2%
28/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
18.9%
7/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
22.2%
8/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Pain
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
11.1%
14/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
11.1%
4/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Pyrexia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
16.7%
21/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
21.6%
8/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
16.7%
6/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
General disorders
Xerosis
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
42.1%
53/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Immune system disorders
Drug hypersensitivity
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
7.1%
9/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Bronchitis
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Candida infection
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.4%
3/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Eye infection
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
3.2%
4/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Eyelid infection
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Fungal infection
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Metabolism and nutrition disorders
Dehydration
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
13.9%
5/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Impetigo
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
9.5%
12/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Localised infection
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
4.0%
5/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Nail infection
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
4.0%
5/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
13.9%
5/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Nasopharyngitis
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
7.1%
9/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Paronychia
50.0%
2/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
49.2%
62/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
16.2%
6/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
33.3%
12/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Pneumonia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Rhinitis
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
4.8%
6/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Skin infection
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
4.8%
6/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.3%
3/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Upper respiratory tract infection
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
4.8%
6/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.1%
3/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.3%
3/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Infections and infestations
Urinary tract infection
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.7%
11/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
13.5%
5/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
16.7%
6/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Investigations
Haemoglobin decreased
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.4%
3/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Investigations
Weight decreased
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
7.9%
10/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
13.5%
5/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
11.1%
4/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Metabolism and nutrition disorders
Appetite disorder
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
7.1%
9/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
18.3%
23/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.1%
3/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Metabolism and nutrition disorders
Hypomagnesaemia
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
29.4%
37/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.1%
3/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
30.6%
11/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
4.0%
5/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.3%
3/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Metabolism and nutrition disorders
Hypophosphataemia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
13.5%
17/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
13.9%
5/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Musculoskeletal and connective tissue disorders
Back pain
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
21.4%
27/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
24.3%
9/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
27.8%
10/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Musculoskeletal and connective tissue disorders
Flank pain
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
4.0%
5/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Musculoskeletal and connective tissue disorders
Muscle spasms
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
11.1%
14/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.1%
3/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
11.1%
4/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.7%
11/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
9.5%
12/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Musculoskeletal and connective tissue disorders
Pain in extremity
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
9.5%
12/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.3%
3/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Musculoskeletal and connective tissue disorders
Pain in jaw
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Nervous system disorders
Cognitive disorder
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Nervous system disorders
Dizziness
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
13.5%
17/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
16.2%
6/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
16.7%
6/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Nervous system disorders
Dysgeusia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
7.9%
10/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Nervous system disorders
Headache
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
42.1%
53/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
27.0%
10/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
27.8%
10/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Nervous system disorders
Memory impairment
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Nervous system disorders
Neuropathy peripheral
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.7%
11/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Nervous system disorders
Peripheral motor neuropathy
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Nervous system disorders
Peripheral sensory neuropathy
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
7/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Psychiatric disorders
Anxiety
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Psychiatric disorders
Depression
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
4.0%
5/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Psychiatric disorders
Insomnia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.7%
11/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
13.5%
5/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
13.9%
5/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Renal and urinary disorders
Dysuria
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
7.1%
9/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Renal and urinary disorders
Haemoglobinuria
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Reproductive system and breast disorders
Pelvic pain
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Cough
50.0%
2/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
32.5%
41/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
27.0%
10/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
30.6%
11/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
7.9%
10/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.1%
3/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
26.2%
33/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
18.9%
7/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
19.4%
7/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Epistaxis
50.0%
2/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
19.8%
25/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
13.5%
5/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Hiccups
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Vascular disorders
Hot flush
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Vascular disorders
Intra-abdominal haematoma
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Nasal dryness
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.4%
3/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.1%
3/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
10.3%
13/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.1%
3/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
11.9%
15/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
10.8%
4/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
11.1%
4/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Skin and subcutaneous tissue disorders
Alopecia
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
12.7%
16/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
13.9%
5/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Skin and subcutaneous tissue disorders
Dermatitis acneiform
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
17.5%
22/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
18.9%
7/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
25.0%
9/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Skin and subcutaneous tissue disorders
Dry skin
50.0%
2/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
31.0%
39/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
13.5%
5/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
36.1%
13/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
11.1%
14/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Skin and subcutaneous tissue disorders
Exfoliative rash
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.4%
3/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
2/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Skin and subcutaneous tissue disorders
Hair growth abnormal
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.4%
3/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
8.3%
3/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Skin and subcutaneous tissue disorders
Hirsutism
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
13.5%
17/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Skin and subcutaneous tissue disorders
Hyperhidrosis
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Skin and subcutaneous tissue disorders
Pain of skin
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
7.9%
10/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Skin and subcutaneous tissue disorders
Photosensitivity reaction
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
6.3%
8/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Skin and subcutaneous tissue disorders
Pruritus
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
39.7%
50/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.7%
1/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
16.7%
6/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Skin and subcutaneous tissue disorders
Rash
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
84.1%
106/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
37.8%
14/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
47.2%
17/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Skin and subcutaneous tissue disorders
Rash erythematous
50.0%
2/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Skin and subcutaneous tissue disorders
Rash macular
50.0%
2/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Skin and subcutaneous tissue disorders
Skin fissures
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
61.9%
78/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
13.5%
5/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
44.4%
16/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Skin and subcutaneous tissue disorders
Skin hypertrophy
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
1.6%
2/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.4%
2/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Skin and subcutaneous tissue disorders
Skin irritation
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
7/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Skin and subcutaneous tissue disorders
Skin reaction
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Vascular disorders
Haematoma
25.0%
1/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.79%
1/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
2.8%
1/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
Vascular disorders
Haemorrhage
0.00%
0/4 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
5.6%
7/126 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/37 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.
0.00%
0/36 • Up to 915 days
32 patients in the 'Afa40-mono' group had disease progression and were transitioned to treatment with 'Afa40+Ctx500'. Thus the total of 203 patients (4+126+37+36) minus the 321 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.

Additional Information

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Phone: 1-800-243-0127

Results disclosure agreements

  • Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
  • Publication restrictions are in place

Restriction type: OTHER