Trial Outcomes & Findings for tTF-NGR Phase I Study (NCT NCT02902237)

Last Updated: 2020-12-08

Results Overview

DLT will be characterized by clinical, blood and serum monitoring at specified time points before and during study period. AE, SAE, and SUSAR reporting was according to CTCAE 4.0 and GCP guidelines.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

Measures: daily during treatment, weekly during rest periods of 2 weeks, monthly after End of Therapy, up to 3 months.

Results posted on

2020-12-08

Participant Flow

All patients were recruited in the University Hospital Muenster on an out-patient basis.

24 patients were screened, 6 were screening failures(1: fast disease progression, 1: retraction of consent; 3: fast disease progression, 1: new brain metastasis diagnosed in screening). One patient died from sepsis before treatment with tTF-NGR, 17 patients obtained at least 1 application of tTF-NGR and were evaluable for safety, toxicity ans efficacy.

Participant milestones

Participant milestones
Measure	tTF-NGR tTF-NGR will be given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks and following cycles with dose escalation of 0.5 mg/m2 upon judgement of tolerability and therapeutic activity. Starting dose will be 1 mg/m2/day. Dose-escalation is stopped before the maximum number of 8 escalation steps if tumor response, tumor progression or a Dose-Limiting Toxicity (DLT) is observed.
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

tTF-NGR Phase I Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	tTF-NGR n=17 Participants This was a single-arm, mono-center, open-label trial. tTF-NGR was given as a 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks to all 17 patients treated. 8 patients received 2 cycles, 1 patient received 3 cycles, and 8 patients received 1 cycle.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Germany	17 Participants n=5 Participants
Disease type germ cell tumor	3 Participants n=5 Participants
Disease type hepatocellular tumor	2 Participants n=5 Participants
Disease type lung tumor	2 Participants n=5 Participants
Disease type colorectal tumor	4 Participants n=5 Participants
Disease type soft tissue sarcoma	5 Participants n=5 Participants
Disease type thyroid tumor	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measures: daily during treatment, weekly during rest periods of 2 weeks, monthly after End of Therapy, up to 3 months.

Population: All 17 patients treated with tTF-NGR were analysed for safety and toxicity.

DLT will be characterized by clinical, blood and serum monitoring at specified time points before and during study period. AE, SAE, and SUSAR reporting was according to CTCAE 4.0 and GCP guidelines.

Outcome measures

Outcome measures
Measure	tTF-NGR n=17 Participants All 17 patients obtaining at least 1 dose of tTF-NGR were analysed for MTD and DLT.
Maximum Tolerated Dose (MTD) and Dose-limiting Toxicity (DLT) MTD (3 mg/m^2 tTF-NGR/day x 5, q day 22)	8 Participants
Maximum Tolerated Dose (MTD) and Dose-limiting Toxicity (DLT) DLT: isolated and reversible elevation of Troponin T hs (grade 3 CTCAE 4.0)	5 Participants
Maximum Tolerated Dose (MTD) and Dose-limiting Toxicity (DLT) other patient, who obtained other doses than MTD without DLT	4 Participants

SECONDARY outcome

Timeframe: 1: Tumor blood flow: baseline, 5 h post-dose, at 5 d at each cycle of therapy and 6 months. 2: Pharmacokinetic measures: 0 h, 0.5 h, 1 h, 1.5 h, 3 h, 2.5 h, 3 h, 3.5 h, 4 h, 4.5 h, 5 h post-dose

Population: All 17 patients obtaining at least 1 dose of tTF-NGR were analysed for efficacy and were assayed for tTF-NGR pharmacokinetics.

1: Anti-tumor activity: Tumor blood flow was measured with MRI and/or CEUS; 2: Pharmacokinetic data of tTF-NGR: tTF-NGR blood levels were analyzed by TF-ELISA.

Outcome measures

Outcome measures
Measure	tTF-NGR n=17 Participants All 17 patients obtaining at least 1 dose of tTF-NGR were analysed for MTD and DLT.
1: Assessment of Anti-tumor Activity: MRI K-trans in [ 10^-3/Min] and/or CEUS in [Arbitrary Units]; 2: Pharmacokinetic Profile: AUC in [ng*h/mL] Anti-tumor activity: blood flow reduction · no	0 Participants
1: Assessment of Anti-tumor Activity: MRI K-trans in [ 10^-3/Min] and/or CEUS in [Arbitrary Units]; 2: Pharmacokinetic Profile: AUC in [ng*h/mL] Pharmacokinetic profile: AUC determined · yes	17 Participants
1: Assessment of Anti-tumor Activity: MRI K-trans in [ 10^-3/Min] and/or CEUS in [Arbitrary Units]; 2: Pharmacokinetic Profile: AUC in [ng*h/mL] Anti-tumor activity: blood flow reduction · yes	17 Participants
1: Assessment of Anti-tumor Activity: MRI K-trans in [ 10^-3/Min] and/or CEUS in [Arbitrary Units]; 2: Pharmacokinetic Profile: AUC in [ng*h/mL] Pharmacokinetic profile: AUC determined · no	0 Participants

Adverse Events

tTF-NGR Dose: 1,0 mg/m^2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

tTF-NGR Dose: 1,5 mg/m^2

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

tTF-NGR Dose: 2,0 mg/m^2

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

tTF-NGR Dose: 2,5 mg/m^2

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

tTF-NGR Dose: 3,0 mg/m^2

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

tTF-NGR Dose: 4,0 mg/m^2

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

tTF-NGR Dose: 5,0 mg/m^2

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	tTF-NGR Dose: 1,0 mg/m^2 n=1 participants at risk tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks	tTF-NGR Dose: 1,5 mg/m^2 n=2 participants at risk tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks	tTF-NGR Dose: 2,0 mg/m^2 n=2 participants at risk tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks	tTF-NGR Dose: 2,5 mg/m^2 n=2 participants at risk tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks	tTF-NGR Dose: 3,0 mg/m^2 n=8 participants at risk tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks	tTF-NGR Dose: 4,0 mg/m^2 n=5 participants at risk tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks	tTF-NGR Dose: 5,0 mg/m^2 n=3 participants at risk tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks
Investigations Troponin T increased	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	12.5% 1/8 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	40.0% 2/5 • Number of events 2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	66.7% 2/3 • Number of events 2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Vascular disorders Transient ischaemic attack	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	12.5% 1/8 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Vascular disorders Deep vein thrombosis (DVT)	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	20.0% 1/5 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	33.3% 1/3 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
General disorders Pyrexia	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	20.0% 1/5 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
General disorders Ataxia	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	12.5% 1/8 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	20.0% 1/5 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Gastrointestinal disorders Lower gastrointestinal haemorrage	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	20.0% 1/5 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Infections and infestations Device related infection	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	12.5% 1/8 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.

Other adverse events

Other adverse events
Measure	tTF-NGR Dose: 1,0 mg/m^2 n=1 participants at risk tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks	tTF-NGR Dose: 1,5 mg/m^2 n=2 participants at risk tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks	tTF-NGR Dose: 2,0 mg/m^2 n=2 participants at risk tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks	tTF-NGR Dose: 2,5 mg/m^2 n=2 participants at risk tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks	tTF-NGR Dose: 3,0 mg/m^2 n=8 participants at risk tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks	tTF-NGR Dose: 4,0 mg/m^2 n=5 participants at risk tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks	tTF-NGR Dose: 5,0 mg/m^2 n=3 participants at risk tTF-NGR was given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks
Investigations Blood bilirubin increased	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Vascular disorders Haemoptysis	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Vascular disorders Hypotension	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	20.0% 1/5 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
General disorders Fatigue	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
General disorders General physical health deterioration	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
General disorders Pyrexia	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	25.0% 2/8 • Number of events 2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	60.0% 3/5 • Number of events 3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	33.3% 1/3 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
General disorders Oedema peripheral	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	12.5% 1/8 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
General disorders Hyperhidrosis	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	12.5% 1/8 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Investigations Aspartate aminotransferase increased	100.0% 1/1 • Number of events 2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Investigations Alanine aminotransferase increased	100.0% 1/1 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Investigations Blood alkaline phosphatase increased	100.0% 1/1 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Investigations Blood lactate dehydrogenase increased	100.0% 1/1 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Investigations Alpha 1 foetoprotein increased	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Investigations Blood cholinesterase decreased	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Investigations Plasmin inhibitor decreased	100.0% 1/1 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Investigations Fibrin D dimer increased	100.0% 1/1 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	20.0% 1/5 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Investigations Antithrombin III decreased	100.0% 1/1 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Investigations Blood lactic acid increased	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	20.0% 1/5 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Investigations N-terminal prohormone brain natriuretic peptide increased	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	20.0% 1/5 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Investigations Lipase increased	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	20.0% 1/5 • Number of events 2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Investigations Amylase increased	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	20.0% 1/5 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Investigations Blood creatinine increased	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	20.0% 1/5 • Number of events 2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Investigations Troponin T increased	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	12.5% 1/8 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	40.0% 2/5 • Number of events 2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Cardiac disorders Supraventricular tachycardia	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Cardiac disorders Chest pain	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	12.5% 1/8 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	20.0% 1/5 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	12.5% 1/8 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	12.5% 1/8 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	33.3% 1/3 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Blood and lymphatic system disorders Thrombocytopenia	100.0% 1/1 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	25.0% 2/8 • Number of events 2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Blood and lymphatic system disorders International normalized ratio increased	100.0% 1/1 • Number of events 2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Blood and lymphatic system disorders Acitvated partial thromboplastin time prolonged	100.0% 1/1 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Blood and lymphatic system disorders Anaemia	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	100.0% 2/2 • Number of events 2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	40.0% 2/5 • Number of events 2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Nervous system disorders Headache	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	12.5% 1/8 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	33.3% 1/3 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Nervous system disorders Head discomfort	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	12.5% 1/8 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Nervous system disorders Vertigo	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	20.0% 1/5 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Gastrointestinal disorders Nausea	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	100.0% 2/2 • Number of events 2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	12.5% 1/8 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	20.0% 1/5 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Gastrointestinal disorders Constipation	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Gastrointestinal disorders Vomiting	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	40.0% 2/5 • Number of events 2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	12.5% 1/8 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	20.0% 1/5 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Renal and urinary disorders Urinary tract infection	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Renal and urinary disorders Haematuria	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	12.5% 1/8 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	33.3% 1/3 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	20.0% 1/5 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	33.3% 1/3 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	20.0% 1/5 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	33.3% 1/3 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	20.0% 1/5 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	20.0% 1/5 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.
Infections and infestations Bacterial infection: Device related infection	0.00% 0/1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	50.0% 1/2 • Number of events 1 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/2 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/8 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/5 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.	0.00% 0/3 • All adverse events including serious adverse events were monitored from the first study-related procedure (tTF-NGR application) ,daily during treatment, weekly during rest periods of 2 weeks, monthly from the end of treatment with tTF-NGR up to 3 months. AE, SAE, SUSAR were classified according to CTCAE 4.0 criteria and reports were generated according to GCP guidelines.

Additional Information

Prof. Dr. Wolfgang Berdel, Professor of Medicine

Department of Medicine A, University Hospital Muenster, Germany

Phone: +49 251 835

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place